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RECRUITING
NCT07896941
PHASE1/PHASE2

Safety and Efficacy of CG-BM1 in Ischemic Stroke

Sponsor: GuangZhou Cellgenes Biotechnology Co., Ltd.

View on ClinicalTrials.gov

Summary

1. To evaluate the safety and tolerability of CG-BM1 for the treatment of patients with Ischemic Stroke. 2. To observe the preliminary effectiveness of CG-BM1 in treating Ischemic Stroke patients.

Official title: A Clinical Trial to Evaluate the Safety and Efficacy of Allogeneic Human Bone Marrow Mesenchymal Stem Cell (CG-BM1) Injection in the Treatment of Ischemic Stroke

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

87

Start Date

2024-09-30

Completion Date

2029-12-30

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

BIOLOGICAL

single infusion, 1.0 × 10^6 cells/kg

CG-BM1

BIOLOGICAL

single infusion, 2.0 × 10^6 cells/kg

CG-BM1

BIOLOGICAL

single infusion, 3.0 × 10^6 cells/kg

CG-BM1

BIOLOGICAL

1.0 × 10^6 cells/kg once every two weeks for a total of 3 doses

CG-BM1

BIOLOGICAL

2.0 × 10^6 cells/kg once every two weeks for a total of 3 doses

CG-BM1

BIOLOGICAL

3.0 × 10^6 cells/kg once every two weeks for a total of 3 doses

CG-BM1

BIOLOGICAL

Placebo, once every two weeks for a total of 3 doses.

Placebo

Locations (1)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, China